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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010678
Receipt No. R000012487
Scientific Title Phase II study of gemcitabine, S-1, leucovorin combination therapy for advanced biliary tract cancer
Date of disclosure of the study information 2013/05/15
Last modified on 2014/12/09

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Basic information
Public title Phase II study of gemcitabine, S-1, leucovorin combination therapy for advanced biliary tract cancer
Acronym Phase II study of GSL combination therapy for advanced biliary tract cancer
Scientific Title Phase II study of gemcitabine, S-1, leucovorin combination therapy for advanced biliary tract cancer
Scientific Title:Acronym Phase II study of GSL combination therapy for advanced biliary tract cancer
Region
Japan

Condition
Condition Unresectable or recurrent biliary tract cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of GEM+S-1+LV combination therapy for advanced biliary tract cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Overall survival, response rate, adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 GEM+S-1+LV combination therapy
GEM: 1,000mg/m2, day1
S-1: 80mg/day(BSA<1.25/m2)
100mg/day(1.25/m2=<BSA<1.5/m2)
120mg/day(BSA=>1.5/m2), day1-7
LV: 50mg/day, day1-7
repeated every 2 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with unresectable or post-operative recurrent biliary tract cancer
2) Patients with pathologically proven biliary tract cancer
3) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2
4) Patients of age >= 20 years
5) Patients have an ability for a sufficient oral intake
6) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, neutrophil >= 1,500/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal, normal echocardiogram
7) Patients who expect to survive more than two months.
8) Written informed consent is required from all patients.
Key exclusion criteria 1) Patients with a previous history of a severe drug hypersensitivity
2) Patients with an active concomitant infection
3) Patients with severe comobidities (cardiovascular disease, renal failure, hepatic failure, digestive ulcer, and gastrointestinal bleeding).
4) Patients with an active pulmonary fibrosis or interstitial pneumonia
5) Patients with severe diahrrea
6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception
7) Patients with uncontrollable massive pleural effusion or massive ascites
8) Patients with an active concomitant malignancy
9) Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Isayama
Organization The University of Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email isayama-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naminatsu Takahara
Organization The University of Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email takaharan-int@h.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 09 Day
Last modified on
2014 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012487

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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